MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. 24K NEURO PROBE SHORT

Catalog Number 1523000M7P

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 06/17/2014

Event Type  Injury  

Event Description

This is the third of four reports (same pt, same incident, different product ids/serial numbers).This report is in regard to the 24k neuro probe short with serial number (b)(4).Linked to mfg report number: 8010219-2014-00033 (1523000m7p; 24k neuro probe short with serial number (b)(4)), mfg report number 8010219-2014-00032 (1517079 selector sterile tubing kit) and mfr report number 3006697299-2014-00066 (cusanxt; cusa nxt console (115-230v) serial number (b)(4)).It was reported that the 24 neuro handpieces were leaking out of the back of the handpieces.The handpiece was switched out to a second loaner handpiece but it did the same thing.The sales representative had the irrigation up to 20 and she did lower it to 14.The pt got a thermal burn on the lateral wall of the inner eyelid.The surgeon said the handpiece was too hot and burned the pt.The surgeon would have to repair the burn before closing.There was a surgical delay of 1 hour.Additional info was received from the sales representative on (b)(4) 2014 with the following: during an orbital decompression case, the length of time the product was in use before the leak was observed was 10 seconds for the first handpiece then the handpiece was switched to the second handpiece and the leak was also immediate.The surgeon used 2 minutes 12 seconds for ultrasonic time.The irrigation was lowered from 20 to 14 when the second handpiece was being used, may be after 15 seconds.It was lowered because there was too much irrigation going down the surgeon's arm.The surgeon also said he had plenty of irrigation in the sterile field.The sales representative had the irrigation setting mainly at 20 the whole 2:12 time.It was lowered to 14 when it didn't help with the dripping.The sales representative raised it back up to 20.The sales representative did not know which handpiece was the first or second handpiece that was used as they were both in the same sterilization tray.The sales representative did not know which handpiece got too hot and burned the pt.The handpiece;tubing was still leaking when the burned occurred.The selector tubing was not changed at all during the case.The 1 hour surgical delay was due to changing the handpieces out and also at the end of the case, the surgeon had to do a revision to the pt's eyelid.Surgery was completed using the "drill with suckers and irrigation".This was reported to be the surgeon's normal technique.Additional info was received from the surgeon on (b)(6) 2014 with the following: patient age was unavailable at the time of the report.The thermal injury occurred early in the lateral decompression.The surgeon stated the handpiece was energized for only 2 minutes 19 seconds when the problem was identified and the use of the selector was discontinued.The water leak seemed quite minimal and sufficient water was coming out the tip irrigator necessitating the use of an additional suction to clear away the irrigation from the field.The burn occurred on the superior edge of the lateral canthal skin incision, right eye.The areas of thermal injury measured 5 mm x 3 mm and 4 mm x 2 mm.At the end of the case, the area most significantly affected was excised (10 mm x 4 mm) and the wound was closed in a typical fashion.The pt is still healing but appears to be doing well.It is not known if additional intervention for the thermal injury will be required.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: 24K NEURO PROBE SHORT
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP10 4DR; UK SP104DR
• Manufacturer Contact: rowena bunuan ; 315 enerprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 3953455
• MDR Text Key: 4645748
• Report Number: 8010219-2014-00034
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1523000M7P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SERIAL NUMBER (B)(4)); LOT NUMBER 1134133); 24K NEURO PROE SHORT (PRODUCT ID: 1523000M7P,; CUSA NXT; SELECTOR STERILE TUBING KIT (PRODUCT ID 1517079,
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR